ARCHIVED - Glyphosate Tolerant Canola, GT200

FD/OFB-097-255-A
October 1999

Novel Food Information - Food Biotechnology

Health Canada has notified Monsanto Canada Inc. that it has no objection to the food use of the transgenic canola line GT200, which has been developed to be tolerant to broad-spectrum glyphosate containing herbicides, specifically Roundupâ(1). The Department conducted a comprehensive assessment of GT200 according to its Guidelines for the Safety Assessment of Novel Foods (September 1994). These guidelines are based upon internationally accepted principles for establishing the safety of foods derived from genetically modified organisms.

Background:

The following provides a summary regarding the Monsanto Canada Inc. notification to Health Canada and contains no confidential business information.

1. Introduction

The GT200 line of canola (Brassica napus) was developed through a specific genetic modification to be resistant to the activity of glyphosate herbicides. The novel variety was developed from the Westar canola variety by insertion of two genes, one of which is a bacterial derived version of the plant enzyme endogenous 5-enolypyruvylshikimate-3-phosphate synthase (EPSPS) and the other, a bacterial enzyme involved in the degradation of glyphosate. Glyphosate specifically binds to and inactivates EPSPS, which is involved in the biosynthesis of aromatic amino acids such as tyrosine. This enzyme is present in all plants, bacteria and fungi, but not in animals, which do not synthesize their own aromatic amino acids. Thus, EPSPS is normally present in food derived from plant and microbial sources. The modified canola line permits farmers to use glyphosate-containing herbicides, such as Roundupâ, for weed control in the cultivation of canola.

2. Development of the Modified Plant

The GT200 canola line was created by Agrobacterium-mediated transformation in which the transfer- DNA (T-DNA) contained the EPSPS encoding gene from the common soil bacterium, Agrobacterium sp., and the gene encoding for glyphosate degradation. The same constitutive promoter controlled the expression of both of these genes. Southern blot analysis demonstrated that line GT200 contained a single genetic insert, consisting of single copies of the Roundup-Ready™ genes. There was no incorporation of translatable plasmid DNA sequences outside of the T-DNA region.

3. Product Information

The protein expression of both genes were detected in the leaves and seeds of transgenic GT200 canola. The average level of expression in leaf tissue was 0.03 to 0.08 mg/mg fresh weight. Slightly higher levels of these two enzymes, 0.051 and 0.144 mg/mg fresh tissue, respectively, were found in seeds. There were no detectable amounts of DNA or protein in the refined oil of GT200 canola. Other than tolerance to glyphosate herbicides, the disease, pest and other agronomic characteristics of GT200 canola were comparable to non-transgenic Westar canola.

4. Dietary Exposure

The human consumption of canola products is limited to the refined oil. The genetic modification of GT200 canola will not result in any change in the consumption pattern for this product. As the introduced gene products are not detectable in the refined oil produced from transgenic canola, there will be no human exposure to these proteins based on normal consumption patterns.

5. Nutrition

The analysis of nutrients from transgenic GT200 canola and non-transgenic canola did not reveal any significant differences in the levels of crude protein, crude fat, crude fibre, ash and gross energy in either whole seed or processed meal. The consumption of refined oil from GT200 will have no significant impact on the nutritional quality of the Canadian food supply.

6. Safety

Since only the processed oil from transgenic GT200, or lines derived there from, will be available for human consumption and the processing removes proteinaceous material, there are no additional toxicity or allergenicity concerns with this product.

CONCLUSION:

Health Canada's review of the information presented in support of the food use of glyphosate tolerant canola GT200 concluded that this canola does not raise concerns related to human food safety. Health Canada is of the opinion that processed oil from GT200 canola is as safe and nutritious as that available from current commercial canola varieties.

Health Canada's opinion pertains only to the food use of this glyphosate tolerant canola. Issues related to growing glyphosate tolerant canola in Canada and its use as animal feed are addressed separately through existing regulatory processes in the Canadian Food Inspection Agency.

(1) Roundupâ and Roundup Ready™ are registered trademarks of the Monsanto Company (USA).


This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Protection Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

For further information, please contact:

Office of Food Biotechnology
Food Directorate
Health Protection Branch
Health Canada
Tunney's Pasture
Ottawa, Ontario K1A 0L2
Telephone: (613) 941-5535
Facsimile: (613) 952-6400

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